Keytruda - Pembrolizumab

What is Keytruda - Pembrolizumab used for?

Keytruda is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be surgically removed.

Keytruda contains the active substance pembrolizumab

How is Keytruda - Pembrolizumab used?

Treatment with Keytruda should be started and followed by a specialist doctor experienced in the use of anticancer medicines. The medicine can only be obtained with a prescription.

Keytruda is available as a powder for solution for infusion (drip into a vein). The infusion is given at the recommended dose of 2 mg per kilogram body weight over 30 minutes every three weeks. In the event of the occurrence of certain side effects, the doctor may decide to postpone the administration of the doses or, depending on the severity of the effects, to interrupt the treatment. Treatment should continue until the disease gets worse or unmanageable side effects appear.

For more information, see the package leaflet.

How does Keytruda - Pembrolizumab work?

The active substance in Keytruda, pembrolizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) designed to recognize and bind to a specific structure, called an antigen, found in certain cells of the body.

Pembrolizumab was designed to bind and block a receptor called "programmed cell death 1" (PD-1), which cancels the activity of some cells of the immune system (the body's natural defenses) called "T cells". By blocking PD-1, pembrolizumab prevents this receptor from inhibiting these immune cells, increasing the immune system's ability to destroy melanoma cells

What benefit has Keytruda - Pembrolizumab shown during the studies?

Keytruda has been shown to be effective in treating patients with melanoma that is either inoperable or has spread in the body in two main studies.

The first study included 540 patients who had previously been treated with another monoclonal antibody used in melanoma therapy, ipilimumab. Patients were treated with Keytruda at a dose of 2 mg / kg body weight every three weeks or at a dose of 10 mg / kg body weight every three weeks or with chemotherapy (medicines used to treat cancer). Early results showed that, 6 months after the start of treatment, the disease had not worsened in 34% of patients treated with Keytruda compared to 16% of patients treated with chemotherapy.

The second study examined 834 patients not previously treated with ipilimumab, who received Keytruda or ipilimumab. Early results showed that patients treated with Keytruda survived for up to 5.5 months without disease progression compared to 2.8 months in patients treated with ipilimumab. The study also showed that overall survival was greater in subjects treated with Keytruda than in patients treated with ipilimumab. Up to 71% of patients survived at least 12 months after starting treatment compared to 58% of patients treated with ipilimumab.

What is the risk associated with Keytruda - Pembrolizumab?

The most common side effects with Keytruda (which may affect more than 1 in 10 people) are diarrhea, nausea, pruritus, erythema, arthralgia (joint pain) and fatigue, mostly mild to moderate. Other common side effects of Keytruda involved the activity of the immune system, which is responsible for inflammation of the organs. Most side effects cease with adequate therapy or with discontinuation of Keytruda treatment.

For the full list of all side effects reported with Keytruda and its limitations, see the package leaflet.

Why has Keytruda - Pembrolizumab been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Keytruda's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP has taken into account that the results of the available studies, although not definitive, have revealed the benefits of Keytruda in subjects with advanced stage melanoma. The safety profile was considered favorable with respect to other treatments, including ipilimumab and chemotherapy, and side effects are manageable with existing recommendations.

What measures are being taken to ensure the safe and effective use of Keytruda - Pembrolizumab?

A risk management plan has been developed to ensure that Keytruda is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Keytruda, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that makes Keytruda will provide doctors who will be prescribing the medicine with informative material containing information on the use of Keytruda and on the management of side effects, particularly those related to the activity of the immune system. The company will also provide an alert card for patients, accompanied by information on the risks of the medicine and indications on when to contact the doctor when symptoms appear.

The company will also make the final results of the ongoing studies with Keytruda available to confirm the long-term benefits of the medicine. Finally, the company will further evaluate the doses of 2 mg / kg and 10 mg / kg of body weight in specific patients and will perform analyzes to better understand which subjects can benefit most from the Keytruda treatment.